FDA Medical devices recall · October 9, 2024

Tablo Console recall

Read the official FDA notice ↗

Product

Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.

Why was it recalled?

Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if blood loss, less-than 300ml, occurs, the patient may experience hypotension, fatigue, cramps, dizziness, headaches, nausea, and shortness of breath.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

UDI-DI: 00850001011112, 00850001011204. Serial Numbers: 400405, 602382M, 602384M, 602387M, 602400M, 602402M, 601124M, 601156M, 601102M, 601265M, 400109, 602248M, 602659M, 602670M, 602767M, 602769M, 602771M, 601356M, 602421M, 602403M, 400394, 601728M, 601730M, 601731M, 601733M, 601735M, 601736M, 601738M, 601771M, 601772M, 601774M, 600599M, 600614M, 600615M, 600620M, 600631M, 600641M, 600646M, 600648M, 600654M, 600659M, 601337M, 601357M, 601360M, 601361M, 601364M, 601368M, 601384M, 601395M, 601396M, 601422M, 601727M, 602748M, 600189, 601515M, 601513M, 601514M, 601517M, 601518M, 601838M, 601864M, 601870M, 601915M, 601924M, 601823M, 601854M, 601861M, 601887M, 601901M, 601908M, 601923M, 601903M, 601936M, 601945M, 601974M, 601799M, 600484M, 601876M, 601886M, 601938M, 601941M, 600488M, 601129M, 601146M, 601270M, 601298M, 601797M, 601805M, 601812M, 601814M, 601821M, 601855M, 601890M, 601897M, 601932M, 601934M, 600563M, 600569M, 600572M, 600574M, 601952M, 601954M, 601878M, 601899M, 601935M, 601942M, 601943M, 601947M, 601800M, 601811M, 601848M, 601874M, 601516M, 602354M, 600174M, 601955M, 602025M, 602035M, 601598M, 601620M, 601139M, 601149M, 601209M, 601210M, 601218M, 601842M, 602503M, 600261M, 602570M, 602626M, 602629M, 601857M, 601858M, 601862M, 601863M, 601866M, 601709M, 602185M, 602255M, 602257M, 602675M, 602744M, 602747M, 602750M, 602753M, 602754M, 602755M, 602756M, 602757M, 602759M, 601639M, 601640M, 601641M, 601642M, 601643M, 601648M, 602053M, 602075M, 602735M, 602784M, 602798M,

Distribution

US: CA, NY, IL, MO, KY, AZ, PA, FL, GA, AK, NM, VA, NC, SC, OK, AL, MA, OH, MI, WA, ID, TX, TN, WY, IA, LA, NE, IN, AR, NV, WV, CO, NJ, MD, KS, UT, CT, MN, MS, WI, HI, DE, VT, MT, OR, ND. OUS: UAE

States: Alaska Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania South Carolina Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0019-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.